Randomised controlled trial of a home-based physical activity intervention in breast cancer survivors

Randomised controlled trial of a home-based physical activity intervention in breast cancer survivors ABSTRACT Background: To improve adherence to physical activity (PA), behavioural support in the form of behavioural change counselling may be necessary. However, limited evidence of the effectiveness of home-based PA combined with counselling in breast cancer patients exists. The aim of this current randomised controlled trial with a parallel group design was to evaluate the effectiveness of a home-based PA intervention on PA levels, anthropometric measures, health-related quality of life (HRQoL), and blood biomarkers in breast cancer survivors. Methods: Eighty post-adjuvant therapy invasive breast cancer patients (age=53.6±9.4yrs; height=161.2±6.8cm; mass=68.7±10.5kg) were randomly allocated to a six-month home based PA intervention or usual care. The intervention group received face-to-face and telephone PA counselling aimed at encouraging the achievement of current recommended PA guidelines. All patients were evaluated for our primary outcome, PA (International PA Questionnaire) and secondary outcomes, mass, BMI, body fat %, HRQoL, insulin resistance, triglycerides (TG) and total (TC), high-density lipoprotein (HDL-C) and low-density lipoprotein (LDL-C) cholesterol were assessed at baseline and at 6-months. Results: On the basis of linear mixed-model analyses adjusted for baseline values performed on 40 patients in each group, total, leisure and vigorous PA significantly increased from baseline to post-intervention in the intervention compared to usual care (between-group differences, 578.5 MET-min・wk-1, p=.024, 382.2 MET-min・wk-1, p=.010, and 264.1 MET-min・wk-1, p=.007, respectively). Both body mass and BMI decreased significantly in the intervention compared to usual care (between-group differences, -1.6 kg, p=.040, and -.6 kg/m2, p=.020, respectively). Of the HRQoL variables, FACT-Breast, Trial Outcome Index, functional wellbeing, and breast cancer subscale improved significantly in the PA group compared to the usual care group (between-group differences, 5.1, p=.024; 5.6, p=.001; 1.9 p=.025; and 2.8, p=.007, respectively). Finally, TC and LDL-C was significantly reduced in the PA group compared to the usual care group (between-group differences, -.38 mmol・L-1, p=.001; and -.3 mmol・L-1, p=.023, respectively).Conclusions: We found that home-based PA resulted in significant albeit small to moderate improvements in self-reported PA, mass, BMI, breast cancer specific HRQoL, and TC and LDL-C compared with usual care.

针对乳腺癌幸存者的家庭式身体活动干预随机对照试验
摘要
背景：为提升身体活动（physical activity, PA）依从性，可能需要采用行为改变咨询形式的行为支持。但目前针对乳腺癌患者联合咨询的家庭式身体活动干预有效性的相关证据较为有限。本项采用平行组设计的随机对照试验（randomised controlled trial）旨在评估家庭式身体活动干预对乳腺癌幸存者的身体活动水平、人体测量指标、健康相关生活质量（health-related quality of life, HRQoL）及血液生物标志物的影响效果。
方法：本研究纳入80例完成辅助治疗的浸润性乳腺癌患者（年龄：53.6±9.4岁；身高：161.2±6.8cm；体质量：68.7±10.5kg），将其随机分配至为期6个月的家庭式身体活动干预组或常规护理组。干预组接受面对面及电话形式的身体活动咨询，以鼓励受试者达到当前推荐的身体活动指南标准。所有受试者均在基线及6个月随访时接受评估：主要结局指标为身体活动水平（采用国际体力活动问卷（International PA Questionnaire）评估），次要结局指标包括体质量、体质指数（Body Mass Index, BMI）、体脂百分比、健康相关生活质量、胰岛素抵抗、甘油三酯（triglycerides, TG）、总胆固醇（total cholesterol, TC）、高密度脂蛋白胆固醇（high-density lipoprotein cholesterol, HDL-C）及低密度脂蛋白胆固醇（low-density lipoprotein cholesterol, LDL-C）。
结果：基于针对两组各40例患者的基线校正线性混合模型（linear mixed-model analyses）分析结果，与常规护理组相比，干预组的总身体活动、闲暇时间身体活动及高强度身体活动均较基线显著提升（组间差异分别为578.5 MET-min・wk-1，p=0.024；382.2 MET-min・wk-1，p=0.010；264.1 MET-min・wk-1，p=0.007）。与常规护理组相比，干预组的体质量及体质指数均显著降低（组间差异分别为-1.6kg，p=0.040；-0.6kg/m²，p=0.020）。在健康相关生活质量相关指标中，与常规护理组相比，身体活动干预组的乳腺癌患者生活质量量表（FACT-Breast）、试验结果指数（Trial Outcome Index）、功能幸福感及乳腺癌分量表得分均显著提升（组间差异分别为5.1，p=0.024；5.6，p=0.001；1.9，p=0.025；2.8，p=0.007）。最后，与常规护理组相比，干预组的总胆固醇及低密度脂蛋白胆固醇水平显著降低（组间差异分别为-0.38mmol・L-1，p=0.001；-0.3mmol・L-1，p=0.023）。
结论：本研究发现，与常规护理相比，家庭式身体活动干预可使受试者自我报告的身体活动水平、体质量、体质指数、乳腺癌特异性健康相关生活质量以及总胆固醇和低密度脂蛋白胆固醇水平得到显著改善，尽管改善幅度为轻度至中度。